Clinical trial

Study on the Therapeutic Effect of Lifei Xiaoji Wan on Lung Adenocarcinoma in the Early Stage of Ground Glass Nodule (Ia Stage) and Its Effect on Tumor Microenvironment

Name

TCM for early-stage LUAD

Description

This study evaluated the relationship between the clinical efficacy, histopathological changes and tumor microenvironment of the pharmacopharmacologic Lifei Xiaoji Wan in the treatment of early stage lung adenocarcinoma, and improved high-level clinical evidence and action targets for the prevention and treatment of early stage lung cancer by traditional Chinese medicine

Trial arms

Trial start

2022-12-01

Estimated PCD

2025-01-01

Trial end

2025-05-31

Status

Recruiting

Treatment

Lifei Xiaoji Wan

The Lifei Xiaoji Wan consists of ginseng, blackhead,rhubarb, aster, forehu, and thin on.

Arms:

trial group

Conventional treatment with Western medicine

Recommended treatment protocols for patients with Stage Ia NSCLC in the "Chinese Society of Oncology Branch of Lung Cancer Clinical Diagnosis and Treatment Guidelines for Lung Cancer (2021 edition)" and the "Chinese Society of Clinical Oncology (CSCO) Non-small Cell Lung Cancer Diagnosis and Treatment Guidelines 2021".

Arms:

control group

Size

Primary endpoint

Lung Cancer Quality of Life Scale (FACT-L)

There are 36 items in the scale, and each item is scored as 0~4 points, with a total score range of 0-144 points (minimum: 0 points; maximum value: 144 points).Higher dimensions and total scores indicate higher.Change from baseline at month 1 and 2.

TCM symptoms and syndromes

Change from baseline at month 1 and 2.

Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body

Every 1 month, assessed up to 2 months, CT was collected for imaging analysis and measurement.RECIST criteria for tumor efficacy evaluation:The extent of growth or shrinkage of the target lesion (unit: mm).

Eligibility criteria

Inclusion Criteria: * It met the diagnostic criteria of non-small cell lung cancer and was confirmed by pathology, cytology and other relevant examinations. * Preoperative thin-slice CT showed pure ground glass pulmonary nodules with a size of 10mm-30mm. Intraoperative and postoperative pathology indicated adenocarcinoma, and the tumor stage (TNM) was stage Ia. * Age: 18-75 years old * Expected survival \>5 years * Informed consent and sign informed consent Exclusion Criteria: * Patients who have undergone surgery * Patients with serious dysfunction of heart, liver, lung, kidney and other important organs * Patients with mental illness who were unable to complete the study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-04-26

1 organization

Organization

Henan University of Traditional Chinese Medicine